Charles Redfern, MDMarch 11, 2022

FDA 483 - Charles Redfern, MD - March 11, 2022

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An FDA inspection of Charles Redfern, MD in San Diego, CA, a clinical investigator, revealed a significant observation related to the conduct of a clinical study. The firm failed to follow the investigational plan, specifically regarding the administration and completion of PRO-CTCAE questionnaires and adherence to dose modification protocols for study subjects. This indicates a lack of adherence to study protocols during clinical trials.

Company: Charles Redfern, MD
Inspection Date: March 11, 2022
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Christina D. Mello

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